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NCT01186770 · ClinicalTrials.gov registry record · Phase 3

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

A Phase 3 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
804
Enrollment target
2
Study locations

NCT01186770 is a Phase 3 study of Opioid-induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 804 participants, below the 7,071-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01186770, a Phase 3 study of Opioid-induced Constipation, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
804 participants
Enrollment target
2
Study locations

Study Summary

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

Conditions Studied

Opioid-induced Constipation

Interventions

  • DRUG Placebo
  • DRUG Methylnaltrexone

Study Locations (2)

North Carolina

  • PRA International - Raleigh
  • PRA, Intl. - Raleigh

Trial Details

FieldValue
Enrollment Target 804 participants
Start Date 2010-09-01
Est. Completion 2011-09-08
Phase Phase 3

Sponsor

Bausch Health Americas

168 total trials

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What the Registry Record Tells You About NCT01186770

The ClinicalTrials.gov registry entry for NCT01186770 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 804 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,071-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (89% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01186770 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01186770 about?

NCT01186770 is a clinical study titled "A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain". MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

What is the current status of trial NCT01186770?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 804 participants. The study started on 2010-09-01. Estimated completion is 2011-09-08.

What conditions does trial NCT01186770 study?

This clinical trial studies the following conditions: Opioid-induced Constipation.

What interventions are being tested in trial NCT01186770?

The interventions under investigation include: Placebo (DRUG), Methylnaltrexone (DRUG).

Who is sponsoring clinical trial NCT01186770?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01186770 being conducted?

This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.